Aurobindo Pharma arm gets USFDA EIR for Telangana unit
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for Unit-2, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Gaddapotharam Village IDA, Jinnaram Mandal, Sanga Reddy District, Telangana.
The inspection of the facility was conducted by the USFDA from September 23 to 27, 2024. Following the inspection, the unit initially received ten observations from the regulatory agency.
In a regulatory filing with the Bombay Stock Exchange (BSE), Aurobindo Pharma confirmed that the facility has now been classified under the Voluntary Action Indicated (VAI) category.
"The Unit has now received an Establishment Inspection Report (EIR) classifying the facility as Voluntary Action Indicated (VAI)," the company stated in a BSE filing.
Read also: Aurobindo Pharma arm Telangana facility gets 10 USFDA observations
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Read also: USFDA inspection: Aurobindo Pharma arm Telangana facility gets 2 observations
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Read also: Aurobindo Pharma arm CuraTeQ Biologics gets UK MHRA nod for cancer treatment Bevqolva
